Rozex

Package Leaflet: Information for the Patient

Rozex

0.75% (7.5 mg/g) Cream

Metronidazole

Read the package leaflet carefully before using the medicine, as it contains important information for the patient

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Rozex cream and what is it used for
• 2. Important information before using Rozex cream
• 3. How to use Rozex cream
• 4. Possible side effects
• 5. How to store Rozex cream
• 6. Contents of the pack and other information

1. What is Rozex cream and what is it used for

Rozex cream contains the active substance metronidazole.
Metronidazole is a nitroimidazole derivative with antibacterial action.

Indications:

Local treatment of inflammatory lesions such as papules and pustules in rosacea.
Local treatment of skin infections.

2. Important information before using Rozex cream

When not to use Rozex

Warnings and precautions

Before starting treatment with Rozex cream, discuss it with your doctor or pharmacist.
Rozex cream is for external use only. Be careful not to get the medicine in your eyes or on mucous membranes. If the medicine accidentally gets into your eyes, rinse them with plenty of water.
If you experience skin irritation, contact your doctor, who may recommend less frequent application or temporary interruption of treatment.
During treatment, avoid exposure to sunlight and artificial UV radiation sources (e.g., sunlamps).
Metronidazole is a nitroimidazole derivative and should be used with caution in patients with blood disorders. If you have any blood disorder or are taking anticoagulant medicines, inform your doctor.
Do not use the medicine for longer than your doctor recommends.

Rozex and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take, including those obtained without a prescription.
The risk of interactions with systemic medicines is low due to the minimal absorption of Rozex cream after local application. In a few patients taking metronidazole orally, reactions similar to those seen with disulfiram (a medicine used to treat alcoholism) have been observed after drinking alcohol.
Oral metronidazole may enhance the anticoagulant effect of warfarin and coumarin derivatives, leading to prolonged prothrombin time. It is not known whether locally applied metronidazole affects prothrombin time.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

Rozex cream may be used during pregnancy only if your doctor considers it necessary.

Breastfeeding

Do not use the medicine during breastfeeding. Your doctor will decide whether to stop treatment with Rozex or stop breastfeeding.

Fertility

No data available.

Driving and using machines

Rozex cream has no or negligible influence on the ability to drive and use machines.

Rozex cream contains the following excipients:

• -cetyl alcohol, which may cause local skin reactions (e.g., contact dermatitis),
• 22 mg of benzyl alcohol (E1519) per gram. Benzyl alcohol may cause allergic reactions or mild local irritation.

3. How to use Rozex cream

Always use this medicine exactly as your doctor or pharmacist has told you.
If you are not sure, ask your doctor or pharmacist.
Rozex cream is for external use on the skin only. Apply a thin layer of the medicine to the affected areas of the skin twice a day (morning and evening).
Before use, wash the affected areas with a special emulsion for sensitive and delicate skin. After applying Rozex cream, you can use cosmetics that do not cause comedones and do not have a drying effect.
The treatment duration is usually 3 to 4 months. The treatment period should not be extended. However, if there is significant improvement, your doctor may recommend continuing treatment for another 3 or 4 months, depending on the severity of the condition.

Elderly patients

No dose adjustment is necessary in elderly patients.

Use in children

Rozex cream is not recommended for use in children due to the lack of data on safety and efficacy.

Missing a dose of Rozex cream

Apply the missed dose as soon as possible. If it is almost time for the next dose, do not apply a double dose to make up for the missed dose.

In case of accidental ingestion of the medicine

Contact your doctor immediately.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported:
Common (may affect up to 1 in 10 people):
dry skin, redness, itching, skin discomfort (burning, stinging), skin irritation, worsening of rosacea symptoms.
Uncommon (may affect up to 1 in 100 people):
numbness, tingling, and prickling sensation of the skin, metallic taste, nausea.
Not known (frequency cannot be estimated from the available data):
contact dermatitis, skin exfoliation, facial swelling.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Rozex cream

Keep this medicine out of the sight and reach of children.
Store in a temperature below 25°C. Do not freeze.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Rozex cream contains

• The active substance is metronidazole. 1 g of cream contains 7.5 mg of metronidazole.
• The other ingredients are benzyl alcohol (E1519), isopropyl palmitate, glycerol, liquid sorbitol 70% non-crystallizing, emulsifying wax (cetyl alcohol, polysorbate 60), lactic acid and/or sodium hydroxide, purified water.

What Rozex cream looks like and contents of the pack

Rozex is a white to light beige, shiny cream.
Rozex cream is packed in aluminum tubes containing 30 g of cream, in a cardboard box.

Marketing authorization holder and manufacturer:

Marketing authorization holder:
Galderma Polska Sp. z o.o.
ul. Puławska 145
02-715 Warsaw
Poland
phone: +48 22 331 21 80
Manufacturer:
Laboratoires Galderma
Z.I. Montdésir
74540 Alby-sur-Chéran
France
Date of last revision of the leaflet: